Senior Coding Specialist I
Company: Thermo Fisher Scientific
Work Schedule: Standard (Monday–Friday)
Work Environment: Office-Based
About the Role
Thermo Fisher Scientific is seeking a Senior Coding Specialist I to support clinical data coding activities in alignment with regulatory standards and clinical research guidelines.
In this role, you will be responsible for coding medical terminology in clinical trial data while ensuring compliance with Good Clinical Practices (GCP), SOPs/Working Practice Documents (WPDs), and Data Validation Manuals (DVMs). You will contribute to operational excellence across clinical data management projects and support training and mentorship activities within the team.
Thermo Fisher Scientific has supported:
Top 50 pharmaceutical companies
750+ biotechnology companies
2,700+ clinical trials across 100+ countries in the last 5 years
Key Responsibilities
1. Medical Coding & Data Quality
Code medical terminology in accordance with the project Coding Plan and DVM.
Review coding listings and ensure accuracy and consistency.
Identify data issues and coordinate with:
Internal CDM teams
Study sites
Ensure all coding activities comply with:
GCP guidelines
SOPs/WPDs
Departmental quality standards
Deliver coding outputs on time, within budget, and at required quality levels.
2. Issue Resolution & Collaboration
Work with project teams to resolve coding and data issues.
Communicate effectively with internal teams and study stakeholders.
Provide guidance on coding-related questions and processes.
3. Training & Mentorship
Assist in delivering general and study-specific coding training to CDM staff.
Provide ongoing support, direction, and guidance to coding specialists.
Act as a mentor for junior team members in coding practices and standards.
4. Reporting & Documentation
Prepare and deliver project-specific status reports to:
Supervisors
Clients
Maintain accurate documentation of coding activities and deliverables.
Ensure adherence to coding guidelines and operational procedures.
Educational Qualifications
Bachelor’s degree or equivalent qualification in a relevant field.
Equivalent combinations of:
Education
Training
Relevant experience
may also be considered.
Experience Requirements
Minimum 3 years of relevant experience in:
Clinical coding
Medical terminology coding
Clinical data management or related areas
Required Skills & Competencies
Technical & Domain Skills
Strong understanding of medical and clinical terminology.
Knowledge of:
Clinical coding standards
GCP guidelines
SOPs and regulatory requirements
Ability to use interactive clinical data systems and tools.
Analytical & Quality Skills
Strong attention to detail and numerical accuracy.
Good analytical and problem-solving abilities.
Ability to ensure high-quality and compliant deliverables.
Sound judgment in decision-making.
Communication & Collaboration
Strong written and verbal communication skills.
Ability to:
Work with cross-functional teams
Communicate with study sites and internal stakeholders
Strong interpersonal and customer-focused approach.
Personal Attributes
Ability to work independently with minimal supervision.
Strong organizational skills and ability to manage timelines.
Flexibility and adaptability to changing priorities.
Strong commitment to confidentiality of medical and client data.
Working Conditions
Office-based work environment.
Exposure to standard office equipment.
Occasional travel:
Domestic
International
Occasional site visits as required.
Why Join Thermo Fisher Scientific?
At Thermo Fisher Scientific, you will be part of a global organization committed to:
Scientific excellence
High-quality clinical research operations
Collaboration and teamwork
Continuous learning and development
Improving global healthcare outcomes
You’ll work in an environment where precision, innovation, and impact are valued every day.
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in scientific research, healthcare, and laboratory solutions, supporting pharmaceutical and biotechnology companies worldwide to accelerate innovation and improve patient outcomes.
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